Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
Status and phase
Completed
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: exenatide
Drug: biphasic insulin aspart
Details and patient eligibility
About
This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.
Enrollment
373 patients
Sex
All
Ages
18 to 80 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Type 2 diabetes
- HbA1C: At least 8%
- Patients that were never treated with insulin before
- Current therapy with metformin and a sulfonylurea.
Exclusion criteria
- History of recurrent, severe hypoglycemia
- Hepatic insufficiency: ALT, AST or alkaline phosphatase > 2.5 times upper limits of laboratory's normal
- Renal insufficiency: serum creatinine > 1.3 mg/dL (males) or > 1.2 mg/dL (females)
- Severe gastrointestinal disease, including gastroparesis
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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